NCT07655141Toborzás még nem indult1/2. fázis
Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2)
A Phase 1/2 Trial Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of Subcutaneous ePGT121v1-LS in Combination With VRC07-523LS, Added to Standard Antiretroviral Therapy in Infants Living With HIV
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 20.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS and VRC07-523-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in Mozambique and Cameroon. The study will also learn how the body processes ePGT121v1-LS and VRC07-523-LS and whether caregivers and health workers find this treatment approach acceptable. The main questions it aims to answer are: * Are ePGT121v1-LS and and VRC07-523-LS safe and well tolerated in infants living with HIV? * Does adding ePGT121v1-LS and VRC07-523-LS to standard ART increase the number of infants who achieve HIV viral suppression by week 48? * How long does it take participants receiving ePGT121v1-LS and VRC07-523-LS to achieve viral suppression compared with standard treatment alone? * How does ePGT121v1-LS and VRC07-523-LS behave in the body after repeated subcutaneous injections? Researchers will compare infants receiving ePGT121v1-LS and VRC07-523-LS plus ART to infants receiving standard ART plus placebo (saline) to see if ePGT121v1-LS improves HIV viral suppression. Participants will: * Continue taking standard oral ART. * Receive 4 subcutaneous injections of ePGT121v1-LS and VRC07-523-LS or placebo every 12 weeks. * Attend regular clinic visits for safety checks, blood tests, and HIV viral load monitoring. * Have follow-up visits for 48 weeks. * Participate in evaluations of treatment adherence and acceptability from the perspective of caregivers and health workers.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 73 (tervezett)
- Első benyújtás
- 2026. jún. 9.
- Kezdés
- 2027. jan. 1.
- Elsődleges befejezés
- 2029. júl. 1.
- Fő szponzor
- Hospital Universitario 12 de Octubre
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT07655141
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 73
- 2027. jan. 1. és az elsődleges befejezés (2029. júl. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálatot írja le, nem a te helyzetedet.
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Korábbi kezelés
- Participation in other concurrent research studies that, in the opinion of the principal investigator and central team, would interfere with the objectives of this study.
- Previous receipt of bNAbs against HIV.
- Intravenous (IV) immunoglobulins received within 90 days before IMP administration.
- Use of systemic immunosuppressive drugs within 30 days before first IMP administration. Not exclusionary: nasal steroid spray, inhaled steroids, topical steroids, a single course of oral/parenteral prednisone or equivalent at 2 mg/kg/day, and length of therapy \<14 days.
- Unable to receive SC medications.
Más betegség
- Any clinically significant acute or chronic illness or condition at screening that, in the opinion of the principal investigator/designee, renders the participant unfit to participate in the study or jeopardizes the safety or rights of the participant. Including, but not restricted to:
- Evidence of active tuberculosis (TB) disease at the time of enrolment.
- Life-threatening condition associated with a high risk of death within 30 days of enrolment, as determined by the study clinician.
- Severe neurological illness.
- Hemodynamically significant severe congenital heart disease.
- Active malignancies.
- Life-threatening bleeding disorder.
- Chronic or recurrent urticaria or any other chronic dermatological condition that may be confused with local Adverse Reactions (ARs).
- Any social or medical condition in the caregivers that, in the judgement of the investigator, would interfere with protocol adherence, completion of the trial or assessment of safety.
Egyéb
- Serious Adverse Reactions (SARs) to the investigational medicinal product (IMP) or its components.
- Severe acute malnutrition with complications.
- Unwillingness to have blood drawn
Kiket keres a vizsgálat
- Infants from 1 to 365 days old at the time of enrolment.
- Living with HIV-1, diagnosed with an approved assay detecting HIV nucleic acids in blood.
- Weight \> 2.5 kg at enrolment.
- ART-naïve or ≤ 30 days of triple ART at screening (not including prophylaxis in HIV-exposed).
- Clinically stable and can be managed as outpatient (participants identified in-hospital can start the trial at their first routine visit).
- Parent or legal guardian able to provide Informed consent (IC).
Életkor a regiszterben: 1 nap – 1 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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